Phase 1/1b Study of BMS-986463 in Advanced Malignant Tumors
This Phase 1/1b study is testing an experimental medicine known as BMS-986463. It is designed for adults with advanced cancers that have grown or spread, particularly certain types of lung cancer (non-small cell lung cancer), ovarian cancer (high-grade serous ovarian carcinoma), and womb cancer (uterine serous carcinoma). Because this is one of the first times this drug is being given to people, the main goal is safety. Doctors want to see how the human body handles the medicine, monitor any side effects, and find the safest and most effective dose. Taking part involves visiting a specialist hospital clinic for regular health checks, scans, and blood tests. This trial may offer an option for people whose cancer has not responded to standard NHS treatments, although direct personal benefit cannot be guaranteed.
At a glance
What is this study about?
When cancer reaches an advanced stage, it means it has spread from where it first started or has come back after treatment. In many cases, standard treatments like chemotherapy or targeted drugs may stop working over time. This clinical trial is researching a completely new drug, known for now as BMS-986463, to see if it could become a future treatment option for advanced solid tumours.
The trial focuses on specific types of cancer, including non-small cell lung cancer and aggressive forms of ovarian and womb cancer. Because this is a Phase 1 study, the drug is in the very early stages of human testing. The main focus is to check whether it is safe to use, how the body breaks it down, and which dose is best to give patients in future studies.
Taking part in research like this helps scientists understand how new medicines work against cancer cells. While early-phase trials are mainly designed to check safety rather than provide a cure, doctors will also carefully track whether the medicine helps to shrink tumours or slow down their growth.
Key takeaways
- Tests an experimental drug called BMS-986463 for advanced solid cancers.
- Aimed at adults with specific types of lung, ovarian, or womb cancers.
- Primary focus is finding a safe dose and monitoring side effects.
- Participation requires regular hospital visits for tests and scans.
- You are free to leave the trial at any time without affecting your normal care.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with an advanced solid cancer that has spread or cannot be removed with surgery. In particular, researchers are looking for people with advanced non-small cell lung cancer, high-grade serous ovarian cancer, or uterine (womb) serous cancer.
To join, participants generally need to have already tried standard cancer treatments that are available, or their doctor must agree that standard treatments are no longer suitable. Patients also need to be reasonably active and well enough to attend frequent hospital visits and manage day-to-day activities.
People who have active, untreated brain tumours, severe heart problems, or other serious medical conditions may not be able to join. The trial doctor will review your full medical history and perform tests to make sure taking part is as safe as possible for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with an advanced or spreading solid tumour (such as lung, ovarian, or womb cancer).
- My cancer has continued to grow after standard treatments, or standard treatments are not suitable for me.
- I am well enough to attend regular clinic appointments and hospital visits.
- I am willing to undergo regular blood tests, scans, and health checks.
What does participation involve?
If you decide to take part, you will be given the study drug BMS-986463 under close medical supervision at a specialist hospital. You will need to attend regular clinic visits where the research team will monitor you closely. These visits often include physical exams, blood tests, heart checks (like an ECG), and imaging scans (such as CT or MRI scans) to track your general health and see how your cancer is responding. The trial may last several months or longer, depending on how you tolerate the medicine and whether it helps. After you stop taking the drug, the team will continue to check on your health during a follow-up period.
Potential risks and benefits
Locations (3)
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedItaly
Common questions
What is a Phase 1 clinical trial?
A Phase 1 trial is one of the earliest stages of testing a new medicine in humans. Its primary purpose is to find a safe dose and look out for side effects.
Will taking part cure my cancer?
Phase 1 trials are designed to test drug safety rather than guarantee a cure. While doctors hope the treatment helps, there is no promise that your tumour will shrink.
Do I have to pay to join this trial?
No, you do not have to pay for the trial medicine or study-related tests. Some trials may also help cover travel expenses to the hospital.
Can I leave the study if I change my mind?
Yes, taking part is entirely voluntary. You can withdraw your consent and leave the study at any point, and your regular medical team will continue supporting you.
How often will I need to visit the hospital?
Because safety is checked very closely in early-stage trials, you may need to visit the clinic frequently, especially in the first few weeks of treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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